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| ID | Type | Description | Link |
|---|---|---|---|
| n°CPP 03/010/2014 | Other Identifier | Comité de Protection des Personnes Nord-Ouest 1 |
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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| University Hospital, Lille | OTHER |
| Association Programme MALIN | UNKNOWN |
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The purpose of this study is to conduct a randomized controlled trial among 800 socially disadvantaged pregnant women and their families to test the effectiveness of a multi-component home visitation nutrition program, compared to usual care, in promoting healthy feeding practices, lifestyle behaviors and growth in young children.
This randomized controlled trial will test an early home based multi-component intervention program designed to promote healthy feeding practices and lifestyle behaviors in socially disadvantaged pregnant women and their families. It first seeks to build knowledge, skills and social support regarding maternal diet and feeding practices (with a focus on breastfeeding and complementary feeding), and lifestyle behaviors, within the frame of the French Nutrition and Health Program (Programme National Nutrition Santé, PNNS) while accounting for the cultural background and barriers of the targeted population (component 1). It also involves fresh fruit and vegetable baskets, kitchen utensils and cooking devices, being made available at a reduced price from the 3rd trimester of pregnancy to when the toddler is aged 24 months (component 2), along with the provision of follow-on formula, baby and family food vouchers from 6 to 24 months (component 3). The intervention group (n=400) will benefit from these 3 program components. The control group (n=400) will receive usual care, restricted to general information on healthy eating provided by the food guides of the PNNS. The ECAIL study will assess the program's effectiveness on lifestyle behaviors and growth in the first 2 years of life.
Noteworthy, the program evaluated for effectiveness with the ECAIL trial is an existing program, called the MALIN program (https://www.programme-malin.com/), which has been progressively implemented in mainland France since 2012, to the exception of the ECAIL study area. Since 2019, counselling on movement behaviors, including the promotion of physical activity and the prevention of sedentary behaviors (e.g. screen time), has been added to the diet and feeding practices educational component; discount vouchers have further encompassed other healthy foods and products appropriate for all family members; and online sales for kitchen utensils and cooking devices have been started too.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Program | Experimental | Experimental: Intervention Program |
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| Usual Care | Active Comparator | Active comparator: Usual Care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Intervention Program | Behavioral | The home based educational component from the 3rd trimester of pregnancy to when the child is aged 24 months seeks to build knowledge, skills and social support (social cognitive theory, anticipatory guidance) to the parents regarding feeding practices (focussing on breastfeeding and complementary feeding), and lifestyle behaviors, consistent with the French Nutrition and Health Program (PNNS) guidelines (component 1). Fresh fruit and vegetable baskets, kitchen utensils and cooking devices are made available at a reduced price from the 3rd trimester of pregnancy to when the toddler is aged 24 m (component 2), along with the provision of follow-on formula, baby and family food vouchers from 6 to 24 m (component 3). One home visit is scheduled during the 3rd trimester of pregnancy. Another visit will take place in the maternity ward after the child is born. Five further home visits will take place when the child is aged 3, 6, 12, 18 and 24 m. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of vegetable consumption (times/day) at age 2 years | Measured at 2 years using a food frequency questionnaire | 2 years of age |
| Measure | Description | Time Frame |
|---|---|---|
| Breastfeeding initiation rate | Measured at different time points from birth to 2 y (scheduled at birth, 3 months, 6 months, 12 months, 18 months and 24 months of age) using questionnaires | Up to 2 years of age |
| Predominant and any breastfeeding durations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandrine Lioret, PhD | Institut National de la Santé Et de la Recherche Médicale, France | Principal Investigator |
| Delphine Ley, MD, PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Lille | 59037 | France | |||
| Valenciennes Hospital, Monaco Hospital maternity |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41578315 | Derived | Poquet D, de Lauzon-Guillain B, Ley D, Charles MA, Sauvegrain P, Lioret S. Intentions, practices, and social representations regarding breastfeeding among women experiencing social disadvantage: findings from the qualitative component of the ECAIL trial. Int Breastfeed J. 2026 Jan 23;21(1):22. doi: 10.1186/s13006-026-00812-1. | |
| 41162889 |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D057185 | Sedentary Behavior |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D005247 | Feeding Behavior |
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| Société Française de Pédiatrie |
| UNKNOWN |
| Association Française de Pédiatrie Ambulatoire | UNKNOWN |
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| Active comparator: Usual Care | Behavioral | Usual Care reflects the standard treatment currently provided within the frame of the French health care system. One home visit is scheduled during the 3rd trimester of pregnancy. Another visit will take place in the maternity ward after the child is born. Five further home visits will take place when the child is aged 3, 6, 12, 18 and 24 m. If nutritional questions are raised by parents, dieticians will restrict their responses based on the food guides of the PNNS. |
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Measured at different time points from birth to 2 y (scheduled at birth, 3 months, 6 months, 12 months, 18 months and 24 months of age) using questionnaires |
| Up to 2 years of age |
| Age at complementary feeding introduction | Measured at different time points from birth to 2 y (scheduled at birth, 3 months, 6 months, 12 months, 18 months and 24 months of age) using questionnaires | Up to 2 years of age |
| Age at first introduction of processed (but not baby-specific) foods | Measured at different time points from birth to 2 y (scheduled at birth, 3 months, 6 months, 12 months, 18 months and 24 months of age) using questionnaires | Up to 2 years of age |
| Frequency of vegetable consumption (times/day) at age 1 year | Measured at 1 year using a food frequency questionnaire | 1 year of age |
| Dietary patterns at age 1 year | Measured at 1 year using a food frequency questionnaire | 1 year of age |
| Lifestyle patterns at age 1 year | Measured at 1 year using dietary variables from the food frequency questionnaire; and movement behavioral variables (physical activity and sedentary behaviors) measured with a questionnaire. Lifestyle patterns will be derived using principal component analysis | 1 year of age |
| Weight growth velocity over the six first months of life | Weight measured at different time points from birth to 6 months of age | Up to 6 months of age |
| BMI at age 2 years | Weight, length and BMI measured at different time points from birth to 2 y | 2 years of age |
| Proportion of children that are overweight or obese at age 2 years | Weight, length and BMI measured at different time points from birth to 2 y | 2 years of age |
| Dietary patterns at age 2 years | Measured at 2 years using a food frequency questionnaire | 2 years of age |
| Lifestyle patterns at age 2 years | Measured at 2 years using dietary variables from the food frequency questionnaire; and movement behavioral variables (physical activity and sedentary behaviors) measured with a questionnaire. Lifestyle patterns will be derived using principal component analysis | 2 years of age |
| Weight growth curves from birth to 2 y | Weight measured at different time points from birth to 2 y | Up to 2 years of age |
| Length growth curves from birth to 2 y | Length measured at different time points from birth to 2 y | Up to 2 years of age |
| BMI curves from birth to 2 y | BMI measured at different time points from birth to 2 y | Up to 2 years of age |
| Valenciennes |
| 59300 |
| France |
| Lioret S, Sion O, Hincker P, Beghin L, de Lauzon-Guillain B, Cavalli B, Salinier C, Turck D, Perez N, Subtil D, Brun S, Charlier M, Creps E, Dehon A, Le Gal C, Poquet D, Sauvegrain P, Heude B, Deplanque D, Meyran D, Devouge P, Ley D, Charles MA. Home visiting intervention over pregnancy and the first two years of life to promote healthy feeding practices and energy balance-related behaviors and prevent obesity risk in children from socially disadvantaged families: protocol for a participant-blinded, two-arm, parallel-group randomized controlled trial-the ECAIL study. BMC Public Health. 2025 Oct 29;25(1):3659. doi: 10.1186/s12889-025-25004-0. |